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Individualizing Therapy for T2DM Management:
New options and Opportunities
CH Choi
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Targets
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Target
• A: Age
• B: Body weight
• C: Complications
• D: Duration
• E: Life Expectancy
• E: Expense
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Target (elderly)
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Lifestyle
“Not everything that can be counted counts, and not everything that counts can be counted”
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思慮 --諸國亮
故欲思其利,必慮其害
(Complications/ SE);
欲思其成,必慮其敗。(Disease progression)
故仰高者,不可忽其下,(Hypoglycemia)
瞻前者不可忽其后。(Metabolomics)
君子視微知著,見始知終,
禍無從起,此思慮之政也。
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Guideline: AES & EASD
Diabetes Care 2015; 38:S1-S94
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Metformin
• Cost-effective
• Long safe data
• Low hypoglycemic risk
• Weight neutral
• Extra-glycemic effect
• Combination therapy
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Metformin
• GI disturbance
• Twice or three times/day
• Risk of lactic acidosis in significant renal/liver/heart failure
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Sulphonylurea
• Diamicron/ Minidiab/ Daonil/ Amaryl
• Cost-effective, daily dose
• SU receptor insulin secretion
• Hypoglycemia
• Weight gain
• Tolerance
• ? Adverse cardiovascular events
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Role of pioglitazone
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SE of pioglitazone
• Edema and weight gain (+3.6 kg)
• CHF
• Bone fracture (0.5/100 pt yr)
• Macular edema (combined with insulin)
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Pioglitazone & Cancer
• Bladder cancer (FDA 10-yr prospective observational)– 2 yr: HR 1.4 (1.03-2.0)– 5 yr: HR 1.17 (0.79-1.49)– 8 yr: HR 1.07 (0.87-1.30)
• Liver cancer: OR 0.83 (0.72-0.95)• Bladder cancer (meta-analysis): HR 1.23, NNH:
5/100000• Colorectal cancer: OR 0.86 (0.79-0.94)• Lung cancer: RR 0.67 (0.51-0.87)
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Role of pioglitazone
• Insulin resistant patients
– Large waist circumference
– Low HDL
– Fatty liver
• High risk or history of CVD (PROactive)
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GLP-1 secretion & action
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Food
GLP-1GIP
Promotes
Insulin secretionInhibits
gluconeogenesis
Vasodilates
perfusing beds Reduces
appetiteDPP-IV
Inhibits background
Glucagon secretion
Increases
Hypo-dependent
Glucagon secretion
Guyton and Hall. Textbook of Medical Physiology.
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“Regular minds find
similarities in stories; finer
minds detect difference”
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Glycemic parameters for DPP-4i as add-on to MET+SU: A1C reduction
DPP-4i Duration
A1C (%)
Reference
N BL ∆ VS BL
Vildagliptin50 mg BD
24 157 8.8 -1.0 Galvus PI
Sitagliptin100 mg QD
24 115 8.3 -0.6 Januvia PI
Linagliptin5mg QD
24 778 8.2 -0.7 Tradjenta PI
Saxagliptin5mg QD
24 127 8.4 -0.7 Onglyza PI
Alogliptin25mg QD
26 197 8.1 -0.5 Nesina PI
Note: This is not a head-to-head study
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-1.34
-2.44
-3.77
-1.07
-1.49
-3.16
-1.21
-1.83
-3.41
-4
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
Me
an d
iffe
ren
ce f
rom
bas
elin
e (
95
% C
I)
Vildagliptin
Sitagliptin
Saxagliptin*
*
HbA1C FBP 2hBG
In this randomized, open-label, parallel clinical trial, 207 T2DM patients inadequately controlled by dual combination ofmetformin and another traditional oral hypoglycemic agent (glimepiride, acarbose or pioglitazone) were randomized to add-on 5mg saxagliptin group or 100 mg sitagliptin once daily group, or 50 mg vildagliptin twice daily group for 24 weeks. * p < 0.01 forthe between-treatment difference from Vildagliptin.
Li CJ, et al. Diabetol Metab Syndr. 2014 May 31;6:69.
Mean Baseline: 8.75 8.54 8.86 8.79 8.22 8.36 11.98 10.98 11.77
Superior Fasting Blood Glucose Control of Vildagliptin - Comparison from a head-to-head study
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Microvascular complications
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Microvascular complications
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Macrovascular complications
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Primary Results
8th June 2015
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Sitagliptin: Primary Composite Cardiovascular Outcome* PP Analysis for Non-inferiority
* CV death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina
Green JB et al. NEJM 2015; DOI: 10.1056/NEJMoa1501352
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Sitagliptin:Hospitalization for Heart Failure*ITT Analysis
* Adjusted for history of heart failure at baseline
Green JB et al. NEJM 2015; DOI: 10.1056/NEJMoa1501352
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TECOS: Sitagliptin
• Pragmatic study, aiming similar A1c
• Non-inferior for primary composite MACE & secondary hospitalization for CHF
• Different inclusion criteria comparing to SAVOR-TIMI (saxagliptin) & EXAMINE (alogliptin)
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Hospitalisations for heart failure, DPP-4i class effect? - Combined analysis
Analysis DPP-4i’s Placebo HR (95%CI) P value
SAVOR TIMI(n=16,492)
289 (3.5%) 228 (2.8%) 1.27 (1.07,1.51) 0.009
EXAMINE(n=5380)
106 (3.9%) 89 (3.3%) 1.19 (0.89, 1.58) 0.238
TECOS(n=14,671)
228 (3.1%) 229 (3.1%) 1.00 (0.83, 1.20) 0.983
COMBINED ANALYSIS
623 (3.4%) 546 (3.0%)1.14 (0.97, 1.34)
Test for heterogeneity for 3 trials:p=0.178, I2= 42%
Presented at ADA2015 on June 8th, unpublished data
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• CV safety data collected during Phase II and Phase III clinical trials have been pooled and used
in meta-analyses to show the CV safety of the individual DPP-4 inhibitors
FDA Recommendations on Evaluating CV Risk in Drugs Intended to T2DM
FDA recommendation Sitagliptin Saxagliptin Linagliptin Alogliptin Vildagliptin
Trial duration ≥2 years
Duration of trials 12−104 weeks 24 weeks 18−52 weeks 12−26 weeks 12−104 weeks
Independent verification
of CV events
RR ≤1
Upper bound of 95% CI <1.3
Schweizer A et al. Diabetes Obes Metab 2010;12:485–94.
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Vildagliptin is not associated with increased risk of MACE* and its individual components vs comparators
0. 1 1.0 10.0 100.00.01
Vildagliptin
n/N (%)
0.82 (0.61–1.11)85/7102 (1.20)83/9599 (0.86)MACE composite endpoint
0.87 (0.56–1.38)35/7102 (0.49)38/9599 (0.40)Myocardial infarction
0.84 (0.47–1.50)25/7102 (0.35)24/9599 (0.25)Stroke
0.77 (0.45–1.31)28/7102 (0.39)25/9599 (0.26)CV death
Comparators
n/N (%)
M-H RR
(95% CI)
Vildagliptin better Comparator better
*MACE, major adverse cardiovascular (CV) events–non-fatal myocardial infarction, non-fatal stroke or CV death
Vildagliptin = 50 mg qd/bid; M-H RR, Mantel-Haenszel risk ratio
Adapted from McInnes G et al. Poster no 891 presented at the 50th EASD Annual Meeting, Sep 15–19, 2014, Vienna, Austria.
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Vildagliptin is not associated with increased risk of hospitalization of heart failure vs comparators
Vildagliptin 50 mg qd/bid
Vildagliptin 50 mg qd
Vildagliptin 50 mg bid
Vildagliptin
n/N (%)
1.08 (0.68-1.70)32/7102 (0.45)41/9599 (0.43)
1.19 (0.63-2.26)19/2451 (0.78)20/2201 (0.91)
0.99 (0.55-1.77)24/6229 (0.39)21/7398 (0.28)
0. 1 1.0 10.0 100.00.01
Comparators
n/N (%)
M-H RR
(95% CI)
Vildagliptin better Comparator better
*new onset or requiring hospitalization for worsening heart failure.
M-H RR, Mantel-Haenszel risk ratio
Adapted from Evans M et al. Poster no 888 presented at the 50th EASD Annual Meeting, Sep 15–19, 2014, Vienna, Austria.
Vildagliptin 50 mg bid
Incidence and relative risk for vildagliptin vs all comparators (meta-analysis)
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Possible SE of DPP4ISAVOR
SaxagliptinRx Vs Plac
EXAMAlogliptinRx Vs Plac
TECOSSitagliptinRx Vs Plac
VildagliptinRx Vs Plac
(combined)
Pancreatitis 24 Vs 21 12 Vs 8 23 Vs 12 9 Vs 13
CA pancreas 5 Vs 12 0 Vs 0 9 Vs 14 0 Vs 0
Severe hypo 53 Vs 43 18 Vs 16 160 Vs 143 85 Vs 184
Hosp CHF 290 Vs 2303.5% Vs 2.8%HR 1.27 (1.07-
1.51)
160 Vs 89 3.9% Vs 3.3%
228 Vs 2293.1% Vs 3.1%
41 Vs 320.43 Vs 0.45%
Inclusion criteria
Hx or high risk AMI/ACS within 15-90days
Hx of vascular disease
All DM patients
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SGLT2 inhibitor
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Advantages of SGLT2 inhibitors
• Glycemic control through another mechanism
• Oral medication
• Weight loss
• May have advantages in lower SBP & FBS
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Avoid using SGLT2 inhibitors…
• High risk of ketosis– Type 1 DM
– Ketosis-prone type 2 DM
• High risk of dehydration/hypovolumeia– Elderly, especially high fall risk
– Postural hypotension
– On long term diuretics
• High risk of genital infection– Recurrent infection
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GLP-1 analogues
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GLP-1 analogues
• Exenatide (Byetta)
• Liraglutide (Victoza)
• Lixisenatide (Lyxumia)
• …..
• Weekly preparation
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GLP-1 analogues
• Lower A1c 1.0-1.5%
• Significant weight loss
• Combined with insulin
• GI side effects
• ? Increase pulse
• ? Pancreatitis
• ? Durability
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Insulin
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Basal analogues
• Glargine/ Detemir
• Bio-similar glargine
• Degludec
• Peglispro
• …
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有連續血糖檢測功能的胰島素泵 – pump with CGMS
數據傳送器
胰島素泵
感應器
輸注器
整合血糖檢測/胰島素泵系統
配合血糖儀校正和電腦下載圖表
胰島素泵 遙控器
電腦
血糖儀
感應器/ 數據傳送器
紅外數據傳送
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Individualize therapy
• Metformin• DPP-4 inhibitor• Pioglitazone/ SGLT-2 inhibitor/ SU• Acarbose
• Insulin – basal ± bolus• GLP-1 analogues• Combinations• Insulin pump
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Conclusion
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